Automating Quality

Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.

Episode 26

September 4, 2019
Current Hot Trends in the Medical Device Industry

Welcome to the 26th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!    Today’s show is focusing on a topic that has yet to be discussed on the show thus far, and that is the […]

Episode 25

August 6, 2019
How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker

Welcome to the 25th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today’s episode is all about leveraging a risk-based approach to develop, implement, and maintain your IT programs, extending to GxP controls and […]

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How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker

Welcome to the 25th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today’s episode is all about leveraging a risk-based approach to develop, implement, and maintain your IT programs, extending to GxP controls and […]

Episode 24

July 9, 2019
All About the Quality Risk Management Lifecycle

Welcome to the 24th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today’s episode is focusing on quality risk management — the process for systematically identifying, assessing, and controlling risk to the quality of […]

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All About the Quality Risk Management Lifecycle

Welcome to the 24th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today’s episode is focusing on quality risk management — the process for systematically identifying, assessing, and controlling risk to the quality of […]

Episode 23

June 25, 2019
Innovation to Retrovation: Maintaining GTP in a GxP World, with Jay Turner

Welcome to the 23rd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episodes two and ten, Jay Turner! Jay is the […]

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Innovation to Retrovation: Maintaining GTP in a GxP World, with Jay Turner

Welcome to the 23rd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episodes two and ten, Jay Turner! Jay is the […]

Episode 22

June 11, 2019
Justin Lacombe on Quality by Design

Welcome to the 22nd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Justin Lacombe. Justin […]

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Justin Lacombe on Quality by Design

Welcome to the 22nd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Justin Lacombe. Justin […]

Episode 21

May 21, 2019
Michael de la Torre on GMP Inspection Analytics

Welcome to the 21st episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Michael de la […]

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Michael de la Torre on GMP Inspection Analytics

Welcome to the 21st episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Michael de la […]

Episode 20

May 7, 2019
Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting

Welcome to the 20th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This week, Mandy is wrapping up the six-part series focused around quality culture, the virtual pharma environment, and supply chain management; with […]

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Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting

Welcome to the 20th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This week, Mandy is wrapping up the six-part series focused around quality culture, the virtual pharma environment, and supply chain management; with […]

Episode 19

April 23, 2019
Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting

Welcome to the 19th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! This week, Mandy is bringing you the fifth part of the six-part series focused around quality culture, the virtual pharma environment, and supply […]

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Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting

Welcome to the 19th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! This week, Mandy is bringing you the fifth part of the six-part series focused around quality culture, the virtual pharma environment, and supply […]

Episode 18

March 26, 2019
Quality Culture with Lisa Helmonds from MWA Consulting

Welcome to the 18th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Mandy is excited to bring you the fourth part in the six-part series with Lisa Helmonds about virtual companies in the life […]

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Quality Culture with Lisa Helmonds from MWA Consulting

Welcome to the 18th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Mandy is excited to bring you the fourth part in the six-part series with Lisa Helmonds about virtual companies in the life […]

Episode 17

March 12, 2019
Quality Agreements with Lisa Helmonds

Welcome to the 17th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This will be the third part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa […]

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Quality Agreements with Lisa Helmonds

Welcome to the 17th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This will be the third part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa […]

Episode 16

February 26, 2019
Continuous Improvement of Quality Management Systems

Welcome to the 16th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   In this week’s episode, Mandy dives deep into the topic of continuous improvement of quality management systems. She discusses what is meant […]

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Continuous Improvement of Quality Management Systems

Welcome to the 16th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   In this week’s episode, Mandy dives deep into the topic of continuous improvement of quality management systems. She discusses what is meant […]

Episode 15

February 12, 2019
Qualifications and Oversight of Contract Service Providers with Lisa Helmonds

Welcome to episode 2 of the 6-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, […]

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Qualifications and Oversight of Contract Service Providers with Lisa Helmonds

Welcome to episode 2 of the 6-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, […]

Episode 14

January 29, 2019
Key Elements of Virtual Life Sciences Companies with Lisa Helmonds

Welcome to the first episode back in the new year! Your host, Mandy Gervasio, and her co-host, Philippe Gaudreau, the CEO of Solabs, are back to start a very interesting new series.   Continuing their mission to bring more clarity around the world of quality and automation in the area of life sciences, they’ve invited […]

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Key Elements of Virtual Life Sciences Companies with Lisa Helmonds

Welcome to the first episode back in the new year! Your host, Mandy Gervasio, and her co-host, Philippe Gaudreau, the CEO of Solabs, are back to start a very interesting new series.   Continuing their mission to bring more clarity around the world of quality and automation in the area of life sciences, they’ve invited […]

Episode 13

December 11, 2018
Recapping Industry Trends in 2018

Welcome to the 13th episode of Automating Quality,  the show that bridges the gap between automation and your quality management systems. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Being the last episode of the year, Mandy is […]

Episode 12

November 27, 2018
Validating a Cloud-based Solution with Philippe Gaudreau

Welcome to the twelfth episode of Automating Quality,  the show that bridges the gap between automation and your quality management systems. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today’s show is focusing on validating a Cloud-based solution. […]

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Validating a Cloud-based Solution with Philippe Gaudreau

Welcome to the twelfth episode of Automating Quality,  the show that bridges the gap between automation and your quality management systems. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today’s show is focusing on validating a Cloud-based solution. […]

Episode 11

November 13, 2018
How to Build an Effective Training Assessment Program with Brian McNamara

Welcome to the eleventh episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Mandy is joined by her co-host, Philippe Gaudreau, and very special guest: Brian McNamara, the Marketing Director for Questionmark.   Today’s topic of […]

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How to Build an Effective Training Assessment Program with Brian McNamara

Welcome to the eleventh episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Mandy is joined by her co-host, Philippe Gaudreau, and very special guest: Brian McNamara, the Marketing Director for Questionmark.   Today’s topic of […]

Episode 10

October 29, 2018
Social and Collaborative Learning with Jay Turner

Welcome to the tenth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episode two, Jay Turner!   Jay is the CEO and […]

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Social and Collaborative Learning with Jay Turner

Welcome to the tenth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episode two, Jay Turner!   Jay is the CEO and […]

Episode 9

October 15, 2018
Effective Training Methods for Millenials with Graham O’Keeffe

Welcome to the ninth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau, as well as their guest for today: Graham O’Keeffe.   […]

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Effective Training Methods for Millenials with Graham O’Keeffe

Welcome to the ninth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau, as well as their guest for today: Graham O’Keeffe.   […]

Episode 8

October 1, 2018
The Specificities of GCP Quality Systems with Natalie Bourgouin

Welcome to the eighth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau. The focus of this week’s show is the specificities of […]

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The Specificities of GCP Quality Systems with Natalie Bourgouin

Welcome to the eighth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau. The focus of this week’s show is the specificities of […]

Episode 7

September 17, 2018
The Philosophy of Quality with Dr. Richard Prince

Welcome to the seventh episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends, and to provide awareness and tactical guidance to help strategically facilitate change. The focus of today’s show is a topic that is near […]

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The Philosophy of Quality with Dr. Richard Prince

Welcome to the seventh episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends, and to provide awareness and tactical guidance to help strategically facilitate change. The focus of today’s show is a topic that is near […]

Episode 6

September 3, 2018
Data Integrity with Rich Greer

Welcome to the sixth episode of Automating Quality. Today’s topic is data integrity — a current, hot-topic in the regulated space. Mandy is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends.   Today, Mandy is joined by her co-host (and founder and […]

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Data Integrity with Rich Greer

Welcome to the sixth episode of Automating Quality. Today’s topic is data integrity — a current, hot-topic in the regulated space. Mandy is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends.   Today, Mandy is joined by her co-host (and founder and […]

Episode 5

August 20, 2018
The Do’s and Dont’s of Change Management with Rachel Fountain

Welcome to the fifth episode of Automating Quality. Today’s topic is change management — picking up the conversation from their first episode on the topic. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs — and together, they welcome back their guest this week, Rachel Fountain.   Rachel is currently a Principal Consultant, […]

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The Do’s and Dont’s of Change Management with Rachel Fountain

Welcome to the fifth episode of Automating Quality. Today’s topic is change management — picking up the conversation from their first episode on the topic. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs — and together, they welcome back their guest this week, Rachel Fountain.   Rachel is currently a Principal Consultant, […]

Episode 4

August 6, 2018
Measuring Operational Effectiveness with Alan Greathouse

Welcome to the fourth episode of Automating Quality. Today’s topic is operational effectiveness. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and their guest this week, Alan Greathouse, Senior Director of Quality and Service Assurance with the FDA Group.   Alan D. Greathouse has over 15 years of CGMP manufacturing experience focused […]

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Measuring Operational Effectiveness with Alan Greathouse

Welcome to the fourth episode of Automating Quality. Today’s topic is operational effectiveness. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and their guest this week, Alan Greathouse, Senior Director of Quality and Service Assurance with the FDA Group.   Alan D. Greathouse has over 15 years of CGMP manufacturing experience focused […]

Episode 3

July 23, 2018
Phase Appropriate Quality with Mary Senica

Welcome to the third episode of Automating Quality. Today’s topic is phase appropriate quality — a topic that is especially relevant for anyone in the life sciences industry. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and industry veteran, and the Vice President of Quality and Compliance from Eirion Therapeutics, Mary Senica. […]

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Phase Appropriate Quality with Mary Senica

Welcome to the third episode of Automating Quality. Today’s topic is phase appropriate quality — a topic that is especially relevant for anyone in the life sciences industry. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and industry veteran, and the Vice President of Quality and Compliance from Eirion Therapeutics, Mary Senica. […]

Episode 2

July 8, 2018
Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner

Welcome to the second episode of Automating Quality. In this episode, Mandy is joined by Jay Turner of EduJay LLC. Jay’s a self-proclaimed learning and development ninja at his latest entrepreneurial venture, EduJay! He has devoted his career to improving people, processes, and programs to produce business results — everything from implementing learning management systems, […]

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Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner

Welcome to the second episode of Automating Quality. In this episode, Mandy is joined by Jay Turner of EduJay LLC. Jay’s a self-proclaimed learning and development ninja at his latest entrepreneurial venture, EduJay! He has devoted his career to improving people, processes, and programs to produce business results — everything from implementing learning management systems, […]

Episode 1

June 25, 2018
Change Management with Rachel Fountain

Welcome to the first episode of Automating Quality. Today’s show is focused on change management — a vital topic for the Life Sciences and regulated industry. Your host is Mandy Gervasio, Sales Engineer and Quality Best Practice SME at Solabs. She is joined by her co-host, Philippe Gaudreau, CEO of Solabs.   In this episode, […]

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Change Management with Rachel Fountain

Welcome to the first episode of Automating Quality. Today’s show is focused on change management — a vital topic for the Life Sciences and regulated industry. Your host is Mandy Gervasio, Sales Engineer and Quality Best Practice SME at Solabs. She is joined by her co-host, Philippe Gaudreau, CEO of Solabs.   In this episode, […]